In the pharmaceutical industry, the quality of every component directly impacts the safety and efficacy of the final drug product. For intermediates like 2-((3aR,4S,6R,6aS)-6-amino-2,2-dimethyltetrahydro-3aH-cyclopenta[d][1,3]dioxol-4-yloxy)ethanol L-tataric acid (CAS 376608-65-0), rigorous quality control is not just a recommendation; it's a necessity. This article outlines the critical quality control aspects that buyers should scrutinize when sourcing this vital Ticagrelor Intermediate from a manufacturer or supplier.

Why Quality Control is Paramount for CAS 376608-65-0

The synthesis of Ticagrelor is a complex process. Any deviation in the quality of its intermediates can lead to:

  • Reduced reaction yields, increasing manufacturing costs.
  • Formation of unwanted by-products or impurities that are difficult and expensive to remove.
  • Compromised purity of the final Active Pharmaceutical Ingredient (API).
  • Potential safety risks if impurities carry over into the finished drug.

Therefore, a robust quality control framework is indispensable for both the manufacturer and the buyer.

Key Quality Control Parameters for Buyers to Verify:

  • Appearance: The standard specification for CAS 376608-65-0 is White to off-white powder. Visual inspection can be the first step in identifying potential quality issues.
  • Assay/Purity: This is the most critical parameter. Buyers should expect and verify an assay of 98.0%~102.0%. High-performance liquid chromatography (HPLC) is the standard method for determining purity. Always request an HPLC chromatogram along with the COA.
  • Impurity Profiling: Beyond the main component's assay, understanding the nature and levels of impurities is vital. Reputable suppliers provide a detailed impurity profile, identifying key process-related impurities and residual solvents.
  • Water Content: Excessive moisture can affect the stability and reactivity of the intermediate. Karl Fischer titration is commonly used to determine water content, with a specification typically around ≤2.0%.
  • Specific Rotation: For chiral compounds like this intermediate, specific rotation is an important indicator of enantiomeric purity. The specified range is often 8.0°~ 12.0°.
  • Identification Tests: Techniques like Infrared Spectroscopy (IR) or Nuclear Magnetic Resonance (NMR) can be used to confirm the identity of the compound.

Working with a Trusted Manufacturer and Supplier

When you purchase Ticagrelor Intermediate, select a supplier that demonstrates a strong commitment to quality control. As a leading manufacturer in China, we implement stringent QC measures at every stage of production. Our quality assurance processes include:

  • In-house Testing: Advanced analytical laboratories equipped with state-of-the-art instruments for comprehensive testing.
  • Strict Raw Material Control: Ensuring the quality of incoming raw materials to prevent downstream issues.
  • Batch-to-Batch Consistency: Implementing rigorous process controls to guarantee uniformity across production batches.
  • Documentation: Providing complete and accurate Certificates of Analysis (COAs) for every batch, detailing all relevant QC parameters.

Requesting Quotes and Samples

When seeking to buy CAS 376608-65-0, don't hesitate to ask for detailed quality control data and samples for your internal evaluation. We are happy to provide competitive pricing and detailed technical information to facilitate your procurement decisions. Our aim is to be your trusted pharmaceutical intermediate supplier, offering both high-quality products and peace of mind.

By understanding and verifying these quality control parameters, pharmaceutical companies can ensure they are obtaining the highest grade Ticagrelor Intermediate, thereby safeguarding the integrity and success of their drug manufacturing processes.